Dr. Nissen on Nightline | FDA's "Black Box" Warning | FDA's Second "Black Box" Warning


We are no longer accepting cases concerning Avandia



Avandia pulled from market

Avandia will be Pulled from Pharmacies
Starting November 18, 2011

Read the FDA Safety Communication


During an FDA (Food and Drug Administration) public advisory committee meeting held on July 30, 2007 regarding Avandia, Dr. David Graham stated that Avandia’s heart risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market.


Just 11 days before cardiologist Dr. Steven E. Nissen published a landmark study that linked Avandia with a raised risj of heart attacks, Dr. Nissen met face to face with four executives of GSK, the maker of avandia, in a private meeting. Dr. Nissen decided to secretly record the conversation and did not share the contents of the recording until recently during a sit down with the New York Times.


The FDA meeting of a joint panel of outside experts convened to consider whether Avandia should be restricted to use in select patients and branded with prominent warnings or removed from the market altogether.

The FDA advisory panel found that Avandia increases the likelihood of heart attacks and should carry new safety warnings.

The original Avandia label underwent several changes in the seven years leading up to the first black box warning, each time strengthening the label, warning of an increased likelihood of congestive heart failure. On August 14, 2007 the FDA finally issued the first black box warning for Avandia regarding the potential increased risk of heart failure.

On November 19, 2007, a second black box warning was added to the Avandia label regarding the potential increased risk of heart attacks and other myocardial ischemic events.

Dr Nissen on Nightline | FDA's "Black Box" Warning | FDA's Second "Black Box" Warning